Updates on India’s Medical Regulations

Medical devices in India are regulated under the Drugs and Cosmetics Act, which focuses on drugs and not devices. As of now, there are no separate medical device regulations, although a new medical device bill has been pending in India for over 7 years.


To promote investment in the medical device sector, India may soon allow 100% foreign direct investment (FDI) in medical device and equipment manufacturing. This change would allow Western companies to set up wholly owned, Greenfield manufacturing facilities in India. Also, these projects would likely receive automatic approval — unlike FDI in drug manufacturing, which can often get stuck in bureaucratic red tape.


As we noted in our August eNewsletter, India has also recently released quite a few new clinical trial regulations and requirements for drug registrations. The government has further announced that it is planning to exempt certain drugs from local clinical trials. This would apply to drugs that treat serious, life-threatening illnesses like AIDS and cancer. A local clinical trial exemption would also apply during a public health emergency. However, in both cases the drugs must already be approved and safely marketed in developed countries, like the U.S.


Finally, the Indian government is now requiring additional information to be included in certain clinical trial applications. Indian clinical trial applications for new drugs must provide information on “(i) assessment of risk versus benefit to the trial patients, (ii) innovation vis-à-vis existing therapeutic option[s] and (iii) unmet medical need in the country [India].” Companies submitting new drug clinical trial applications in India should make sure that their applications now include this information.